Unrated Drug recall · FDA · Published July 1, 2020

Lidothol Patch Recall: CGMP Deviations in Batch Records

Preferred Pharmaceuticals recalls Lidothol Patches due to lost batch records. Check lot numbers H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1390-2020Drug Lidothol ›

Recall notice

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

Take action

Contact the company

Recalling firmPreferred Pharmaceuticals, Inc.1250 N Lakeview Ave Ste O · Anaheim, CA 92807-1801

✎ GovInfoNow plain-language explainer

Preferred Pharmaceuticals, Inc. is recalling Lidothol Patches containing lidocaine and menthol because the contract manufacturer misplaced or lost batch records and test results for specific lots. This recall affects patches distributed nationwide with expiration dates up to May 31, 2021. The record does not specify a remedy or action required for consumers. Read more at govinfonow.com/recall/36991-lidothol-patch-recall-cgmp-deviations-in-batch-records.

Source Summary by GovInfoNow · govinfonow.com/recall/36991-lidothol-patch-recall-cgmp-deviations-in-batch-records · Updated October 11, 2026 · FDA enforcement record: FDA #D-1390-2020

Cite this page

“Lidothol Patch Recall: CGMP Deviations in Batch Records.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36991-lidothol-patch-recall-cgmp-deviations-in-batch-records. Based on FDA recall #D-1390-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1390-2020%22&limit=1).

The FDA announced on July 1, 2020, that Preferred Pharmaceuticals, Inc. voluntarily recalled Lidothol Patch Lidocaine Menthol due to current good manufacturing practice (CGMP) deviations. The company initiated the recall after a contract manufacturer misplaced batch records and test results for the affected lots.

How to tell if you have it

Brand: Lidothol
Product: Lidothol Patch Lidocaine Menthol
Description: Lidocaine 4.5% & Menthol 5%, 15 patches per box
Insurance NDC: 53225-1025-01
Prod # (NDC): 68788-7405-01
Lot Numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G
Expiration Date: 5/31/2021

The hazard

The recall stems from CGMP deviations where a contract manufacturing organization misplaced or lost batch records and test results for the recalled batch. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Preferred Pharmaceuticals, Inc. has 32 other recalls on record since August 15, 2018. Other recent recalls by the brand include Lidocaine Ointment (September 28, 2026), Geri-Care Eye Drops (March 25, 2026), and Ondansetron ODT (November 17, 2025). Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution (April 1, 2026), Pro N: 5% Lidocaine Tattoo Numbing Spray (February 2, 2026), and Blossom Pharmaceuticals Globe Clotrimazole Cream (October 31, 2025).

How to tell if you have this one

Check your box for the brand Lidothol Patch with Lidocaine 4.5% & Menthol 5%. Look for one of these lot numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, or G0519G. The expiration date on the package should be 5/31/2021.

Brand
Lidothol
Category
Drug

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Jul 1, 2020Firm started the recall
Jul 15, 2020FDA classified it Class II
Jul 22, 2020Published in FDA’s Enforcement Report
Apr 17, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Lidothol recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36991-lidothol-patch-recall-cgmp-deviations-in-batch-records">Lidothol Patch Recall: CGMP Deviations in Batch Records (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1390-2020 (July 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1390-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.